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Study to Assess the Safety and Tolerability of a PARP Inhibitor in Combination With Carboplatin and/or Paclitaxel

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
AstraZeneca Identifier:
First received: August 13, 2007
Last updated: April 3, 2017
Last verified: April 2017
The purpose of this study is to identify a safe and tolerable dose of the drug KU-0059436 that can be given in combination with carboplatin and/or Paclitaxel chemotherapy

Condition Intervention Phase
Triple Negative Metastatic Breast Cancer
Advanced Ovarian Cancer
Drug: KU-0059436 (AZD2281)(PARP inhibitor)
Drug: Carboplatin
Drug: Paclitaxel
Drug: Paclitaxel + Carboplatin
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Phase I, Open-Label Study to Assess the Safety and Tolerability of KU-0059436 in Combination With Carboplatin, KU-0059436 in Combination With a Paclitaxel/Carboplatin T/C Doublet and KU-0059436 in Combination With Paclitaxel in the Treatment of Patients With Advanced Solid Tumours

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • To establish the maximum tolerated dose (MTD) of KU 0059436 in combination with Paclitaxel/Carboplatin [ Time Frame: assessed at each visit ]

Secondary Outcome Measures:
  • To identify the dose limiting toxicity of the combination therapy [ Time Frame: assessed at each visit ]

Enrollment: 192
Actual Study Start Date: June 29, 2007
Estimated Study Completion Date: December 29, 2017
Primary Completion Date: January 4, 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Carboplatin + KU-0059436
Drug: KU-0059436 (AZD2281)(PARP inhibitor)
Other Name: Olaparib
Drug: Carboplatin
intravenous injection
Other Names:
  • Paraplatin®
Experimental: 2.
Paclitaxel + KU-0059436
Drug: KU-0059436 (AZD2281)(PARP inhibitor)
Other Name: Olaparib
Drug: Paclitaxel
Intravenous injection
Experimental: 3.
Paclitaxel, Carboplatin + KU-0059436
Drug: KU-0059436 (AZD2281)(PARP inhibitor)
Other Name: Olaparib
Drug: Paclitaxel + Carboplatin
Intravenous injection


Ages Eligible for Study:   18 Years to 130 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male or female patients with a histologically or cytologically diagnosed malignant solid tumour
  • Adequate bone marrow, hepatic and renal function
  • Performance status of no more than 2 ( ECOG scale).

Exclusion Criteria:

  • Any chemotherapy, radiotherapy ( except palliative), endocrine or immunotherapy within 4 weeks prior to entry
  • Major surgery with 4 weeks of entering the study and must have recovered from effects of the major surgery
  • More than two previous courses of platinum-containing chemotherapy
  • Heavily pre-treated patients(> 2 courses of previous chemotherapy and/or extensive irradiation leading to bone marrow deficiency) will be excluded from the study
  Contacts and Locations
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Please refer to this study by its identifier: NCT00516724

Research Site
Brussels, Belgium
Research Site
Amsterdam, Netherlands
Research Site
Rotterdam, Netherlands
United Kingdom
Research Site
Sutton, Surrey, United Kingdom
Sponsors and Collaborators
Study Director: Jane Robertson, BSc, MBCHB, MD AstraZeneca
Principal Investigator: Dr Johann de Bono, MD Cancer Research UK, The Institute of Cancer Research, London, UK
Principal Investigator: Prof Jan HM Schellens The Netherlands Cancer Institute, Amsterdam, The Netherlands
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: AstraZeneca Identifier: NCT00516724     History of Changes
Other Study ID Numbers: KU36-96
Study First Received: August 13, 2007
Last Updated: April 3, 2017

Keywords provided by AstraZeneca:
malignant solid tumours
Poly(ADP ribose) polymerases

Additional relevant MeSH terms:
Albumin-Bound Paclitaxel
Poly(ADP-ribose) Polymerase Inhibitors
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors processed this record on April 21, 2017